Schizophrenia Clinical Trial
— TSSTOfficial title:
Neuroendocrine and Immune Response to Stress in Schizophrenia
NCT number | NCT01975584 |
Other study ID # | HP-00055151 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | June 2018 |
Verified date | September 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot study. We are testing the physiologic, immune and chemical responses to stress. We believe the results of all measures to stress will be blunted in schizophrenia compared to healthy controls. We will test sex, early life stress and other factors on the relationship to a stress response.
Status | Completed |
Enrollment | 21 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - DSM-IV diagnosis of schizophrenia or schizoaffective disorder (schizophrenia group) - No DSM-IV Axis I or II disorder (healthy control group) - Caucasian or Non-Caucasian Exclusion Criteria: - History of Cushing's syndrome, adrenal deficiency, or any condition that may affect cortisol levels in the body. - Use of steroids - Pregnancy or lactation. Pregnancy will be determined by urine pregnancy test. Lactation will be determined through patient report. - Untreated hypertension, cardiac arrthymias or medical condition that could not handle stress. |
Country | Name | City | State |
---|---|---|---|
United States | Maryland Psychiatric Research Center | Catonsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 1) To examine neuroendocrine and physiologic response following a psychosocial stressor in people with schizophrenia and healthy controls. | We will administer the Trier Social Stress Test (TSST) and measure neuroendocrine values (plasma and salivary cortisol and adrenocorticotropic hormone (ACTH) and physiologic variables (heart rate, blood pressure) before during and after the TSST. | 1 week | |
Secondary | To investigate neuroimmune and kynurenic acid modulation to a psychosocial stressor in people with schizophrenia and healthy controls | We will measure peripheral cytokine response (IL-6, IL1-Beta, TNF alpha) and kynruenic acid, kynurenine and pathway metabolites before, during and after the TSST. | 1 week |
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